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Model Number URF-V |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation was confirmed as insertion tube detachment was observed.As a result of the insertion tube falling off, water tightness was also not maintained.The tip cover was burnt, the forceps could not be inserted smoothly into the forceps channel, and the light guide bundle was burning.Additionally, mark peeling of the of the rotation mechanism part was recognized, scratches were found on the grip, paint floating was recognized on the up/down plate, scratches and wrinkles were both found on the universal cord, scratches were found on the video connector case and there were scratches on the up/down angle fixing lever.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus that while using the uretero-reno videoscope, the corrugated tube was falling off and the film was torn.The issue was found during reprocessing; the customer recognized film breakage by detecting water leakage after use.The procedure name was transurethral lithotripsy (fragmentation and removal of urinary stones), and it was completed with the same set of equipment without delay.There was no patient harm associated with the event.The device was returned and evaluated, and insertion tube detachment was observed.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress, handling, or other issues.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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